Yancheng Suhai Pharmaceutical Co. Ltd.
Form 483 issued April 26, 2019 · Yancheng, China
- Inspection
- Apr 22 – Apr 26, 2019
- Observations
- 7
- Pages
- 4
- FEI number
- 3002394098
In short: On April 26, 2019, FDA issued a Form 483 with 7 observations to Yancheng Suhai Pharmaceutical Co. Ltd. in Yancheng, Jiangsu (FEI 3002394098) after an inspection that ran Apr 22 – Apr 26, 2019. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The personnel are not properly trained in their particular job functions and records…
- 02
The flow of in-process materials though the building is not…
- 03
Routine calibration and maintenance of the equipment is not performed according to a written program designed…
- 04
Written procedures have not been properly established for cleaning of equipment and its subsequent release for…
This inspection in context
Questions about this 483
What did FDA find at Yancheng Suhai Pharmaceutical Co. Ltd.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Yancheng Suhai Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Apr 22 – Apr 26, 2019, and the Form 483 is dated April 26, 2019.
How do I get the full Form 483 for Yancheng Suhai Pharmaceutical Co. Ltd.?
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